Technical Feasibility, Short-Term Patency, Safety, and Efficacy of Percutaneously Delivered Double Pig-Tail Stent for Palliation of Unresectable Biliary Malignancies (original) (raw)

A newly designed uncovered biliary stent for palliation of malignant obstruction: results of a prospective study

BMC Gastroenterology

Background: Biliary decompression can reduce symptoms and improve quality of life in patients with malignant biliary obstruction. Endoscopically placed stents have become the standard of care for biliary drainage with the aim of improving hepatic function, relieving jaundice, and reducing adverse effects of obstruction. The purpose of this study was to evaluate the performance characteristics of a newly-designed, uncovered metal biliary stent for the palliation of malignant biliary obstruction. Methods: This post-market, prospective study included patients with biliary obstruction due to a malignant neoplasm treated with a single-type, commercially available uncovered self-expanding metal stent (SEMS). Stents were placed as clinically indicated for palliation of jaundice and to potentially facilitate neo-adjuvant chemotherapy. The main outcome measure was freedom from recurrent biliary obstruction (within the stent) requiring reintervention within 1, 3, and 6 months of stent insertion. Secondary outcome measures included device-related adverse events and technical success of stent deployment. Results: SEMS were placed in 113 patients (73 men; mean age, 69); a single stent was inserted in 106 patients, and 2 stents were placed in 7 patients. Forty-eight patients survived and/or completed the 6 month study protocol. Freedom from symptomatic recurrent biliary obstruction requiring re-intervention was achieved in 108 of 113 patients (95.6, 95%CI = 90.0-98.6%) at study exit for each patient. Per interval analysis yielded the absence of recurrent biliary obstruction in 99.0% of patients at 1 month (n = 99; 95%CI = 97.0-100%), 96.6% of patients at 3 months (n = 77; 95%CI = 92.7-100%), and 93.3% of patients at 6 months (n = 48; 95%CI = 86.8-99.9%). In total, only 5 patients (4.4%) were considered failures of the primary endpoint. Most of these failures (4/5) were due to stent occlusion from tumor ingrowth or overgrowth. Overall technical success rate of stent deployment was 99.2%. There were 2 cases of stent-related adverse events (1.8%). There were no cases of post-procedure stent migration, stent-related perforation, or stent-related deaths.

Comparison of the performance of plastic stents in palliation of proximal and distal malignant biliary obstructions

2011

Aim: To compare the effi cacy of plastic stents in the treatment of distal and proximal stricture of biliary tract neoplasm's. Methods: From January 2002 to February 2009, 70 patients (37 males, 33 females) with non surgically resectable malignant biliary obstruction who received plastic stent implantation were reviewed retrospectively. The stents were inserted by endoscopy. The endoscopist implants one or more stents if he considers this necessary. The end points of the study were stent occlusion and patient death. Results: The mean time of stent patency was 81 ± 75 days in the group of proximal stricture (group 1) and 130 ± 68 days in the group of distal stricture (group 2), (p 0.40, with CI 95% 0.47-1.37). The mean survival time was 126 days in group 1 and 159 days in group 2. There was not a signifi cant difference between the two groups. Conclusion: Plastic stent implantation is a feasible, palliative method for unresectable malignant biliary obstruction. The overall survival and obstruction with the use of plastic stent in patients with distal stenoses compared with proximal obstruction was not signifi cantly different in our study.

Percutaneous transhepatic biliary stenting: The first experience and results of the Hospital of Kaunas University of Medicine

Medicina, 2008

Malignant biliary obstruction may be caused by cholangiocarcinoma and other nonbiliary carcinomas. At the time of diagnosis, 90% of patients with malignant obstructive jaundice may benefit from palliative treatment only. The objective of palliation is to relieve jaundice-related symptoms, prevent cholangitis, prolong survival, and improve quality of life. Percutaneous transhepatic biliary stenting is a well-established procedure used in patients with malignant obstruction of intra- and extrahepatic bile ducts. Twelve patients (9 women, 3 men; mean age, 68 years; range, 44–88 years) with inoperable malignant biliary obstruction were selected for percutaneous transhepatic biliary stenting with metallic stents in the period from January to December 2007. Technical and clinical success rate in this patient series was 83% and 80%, respectively. Minor and major complications occurred in 17% and 8% of cases, respectively, which is in the range reported by the others. This is our first expe...

Malignant biliary stenosis treated with two percutaneous stents--case report

Chirurgia (Bucharest, Romania : 1990)

During last three decades interventional radiology became most powerfull tool in palliative treatment of patients with malignant biliary stenosis. We report a case of 62-year-old patient with malignant biliary obstruction caused by recidivant tumor of common bile duct remnant with infiltration of previously created hepaticojejunostomia. Biliary decompression was achieved by placement of two self-expanding metallic stents. In presented patient, due to previous surgery percutaneous approach was mandatory. Also, considering the unresectability of recidivant lesion and poor prognosis, definitive, preferable internal biliary drainage was to be achieved. Therefore the placement of metallic self-expanding stent was the therapeutic method of choice. The aim of percutaneous minimally invasive radiological interventions is to achieve effective biliary decompression with internal bile drainage if possible.

Double plastic stenting for inoperable malignant biliary stricture among cirrhotic patients as a possible cost-effective treatment

European Journal of Gastroenterology & Hepatology, 2019

Background and study aim Endoscopic retrograde cholangiopancreatography (ERCP) has evolved as the main therapeutic intervention for hepatobiliary disorders. Palliative stenting for inoperable cases is associated with better morbidity and mortality than surgery. This work aimed at assessing the effect of insertion of two plastic stents in inoperable malignant biliary stricture among cirrhotic patients regarding stent patency, quality of life (QOL), and cost. Patients and methods This multicenter study included 72 cirrhotic patients presented for ERCP with an inoperable malignant biliary stricture. All patients underwent ERCP after preoperative optimization with sphincterotomy, balloon dilatation, and insertion of two plastic stents of 10 Fr. Evaluation included stent patency at 6 months, effect on the QOL using EORTC QLQ-C30 (version 3), adverse events, and the cost. Results Patients included 67% of males and had an age range of 48-88 years (mean: 70 years). In all, 92% of stents were patent at 6 months. Significant improvement in serum total bilirubin and all items of QOL questionnaire at 6 months after the procedure was reported. Cholangitis and pancreatitis were reported in 25 and 8% of cases, respectively. The cost of insertion of two plastic stents and the daily cost of the procedure regarding the effect on QOL were low. Conclusion Double plastic stenting of the common bile duct seems effective at 6 months of follow-up among cirrhotic patients with inoperable malignant biliary obstruction. Furthermore, it seems also valuable in improving laboratory findings and QOL among those patients with an acceptable cost.

A comparative study on the efficacy of covered metal stent and plastic stent in unresectable malignant biliary obstruction

Clinical endoscopy, 2012

The placement of self expandable metal stent (SEMS) is one of the palliative therapeutic options for patients with unresectable malignant biliary obstruction. The aim of this study was to compare the effectiveness of a covered SEMS versus the conventional plastic stent. We retrospectively evaluated 44 patients with unresectable malignant biliary obstruction who were treated with a covered SEMS (21 patients) or a plastic stent (10 Fr, 23 patients). We analyzed the technical success rate, functional success rate, early complications, late complications, stent patency and survival rate. There was one case in the covered SEMS group that had failed technically, but was corrected successfully using lasso. Functional success rates were 90.5% in the covered SEMS group and 91.3% in the plastic stent group. There was no difference in early complications between the two groups. Median patency of the stent was significantly prolonged in patients who had a covered SEMS (233.6 days) compared with...

Evaluation of new plastic stents for malignant biliary obstruction

Digestive Endoscopy, 2001

for prevention of dislocation and for keeping the terminal hole of the stent at the center of the bile duct for effective drainage (Fig. 1). Patients and stents All the patients included in this study had inoperable malignant biliary obstruction. Patients with hilar biliary obstruction were excluded. Double layer stents were applied in 24 patients; 15 with pancreatic cancer, four with bile duct cancer, five with other diseases including gallbladder cancer and metastatic tumor, of which the primary lesions were carcinomas of the stomach, liver and urinary bladder. Forty-four patients treated with 10-Fr-sized plastic stents (Olympus, Tokyo, Japan) and 10 patients with covered metallic stents were investigated retrospectively to compare the effectiveness of this new stent (Table 1). The shape of the 10-Fr-sized plastic stent was straight. Internal diameter of this stent was from 6 (proximal end) to 7.2 Fr (distal end) and the length was from 62 to 122 mm. The metallic stent used in this study was the Wallstent (Schneider AG, Bülach, Switzerland), a selfexpanding stent. The diameter of this stent that we used was 10 mm and 40 to 80 mm in length. This metallic stent was covered with polyurethane by our own technique. The method we used to cover the stent included: after the stent was released from the delivery catheter, it is placed inside a small tube of thin glass. Polyurethane solution is poured into this tube and the inside of the tube is dried. After covering, the stent is mounted on a delivery system again. METHODS After endoscopic retrograde cholangiopancreatography and endoscopic sphincterotomy, stents were inserted over a

Should plastic stents be avoided in all unresectable malignant perihilar biliary strictures?

Digestive Endoscopy, 2013

Clinical guidelines of the European Society of Gastrointestinal Endoscopy recommend the insertion of self-expandable metallic stents (SEMS) as opposed to plastic stents (PS) in patients with unresectable malignant perihilar stricture (MHS). However, PS are cheaper and easier to insert into the biliary duct compared to SEMS. Furthermore, PS are removable and easy to move into subsequent drainage procedures. We conducted the present retrospective single-center study to elucidate the predictive factors associated with stent patency period duration in patients with unresectable MHS who would benefit from a long patency period after PS placement. This study included 56 consecutive patients with unresectable MHS who were drained using PS. PS failure occurred in 26 (46.4%) patients. The median patency period was 72 days (95% confidence interval: 29.8-114). The only significant predictive factor associated with the length of the stent patency period was history of previous endoscopic sphincterotomy (EST). Median patency periods with and without previous EST were 28 and 109 days, respectively (P = 0.016). In conclusion, we suggest that conventional biliary drainage with PS is still a suitable option for the treatment of unresectable MHS in patients without previous EST.